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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02939989




Registration number
NCT02939989
Ethics application status
Date submitted
19/10/2016
Date registered
20/10/2016
Date last updated
11/05/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
Scientific title
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
Secondary ID [1] 0 0
2016-002491-26
Secondary ID [2] 0 0
M15-942
Universal Trial Number (UTN)
Trial acronym
MAGELLAN-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - ABT-493/ABT-530
Treatment: Drugs - Ribavirin

Experimental: ABT-493/ABT-530 + SOF + RBV for 16 weeks - ABT-493/ABT-530 (300/120 mg) QD + SOF (400 mg) QD + RBV (600 - 1200 mg) daily in two divided doses (based on baseline age and weight) for 16 weeks.

Experimental: ABT-493/ABT-530 + SOF + RBV for 12 weeks - ABT-493/ABT-530 (300/120 mg) QD + SOF (400 mg) QD + RBV (600 - 1200 mg) daily in two divided doses (based on baseline age and weight) for 12 weeks.


Treatment: Drugs: Sofosbuvir
Tablet

Treatment: Drugs: ABT-493/ABT-530
Tablet

Treatment: Drugs: Ribavirin
Tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with sustained virologic response 12 weeks post dosing (SVR12) - Percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (LLOQ) (less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Timepoint [1] 0 0
12 weeks after last dose of study drug
Secondary outcome [1] 0 0
Percentage of participants with on-treatment virologic failure. - On treatment virologic failure is defined as confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurement of > 1 log10 IU/mL above nadir) at any time point during treatment; or confirmed HCV RNA = 100 IU/mL (defined as 2 consecutive HCV RNA measurements = 100 IU/mL) after HCV RNA < LLOQ during treatment.
Timepoint [1] 0 0
Treatment Day 1 to end of treatment (up to 12 or 16 weeks depending on treatment arm)
Secondary outcome [2] 0 0
Percentage of participants with post-treatment HCV virologic relapse - Percentage of participants with confirmed quantifiable HCV RNA after completion of treatment among participants with unquantifiable HCV RNA at the end of treatment.
Timepoint [2] 0 0
Up to 24 weeks after last dose of study drug

Eligibility
Key inclusion criteria
- Male or female subjects must be adults (18 years of age or older) or adolescents (12
to less than 18 years of age weighing at least 35 kg).

- Subject must have experienced virologic failure during or after treatment with
ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic
failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or
ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at
AbbVie's discretion. Treatment in the parent study must have been completed or
discontinued at least 1 month prior to the Screening Visit.

- Subjects must be able to understand and adhere to the study visit schedule and all
other protocol requirements.

- Cirrhotic Subjects must have compensated cirrhosis, (Child-Pugh score of = 6) at
Screening and no current or past evidence of Child-Pugh B or C Classification or no
clinical history of liver decompensation, including ascites noted on physical exam,
hepatic encephalopathy or esophageal variceal bleeding.

- Cirrhotic Subjects must have absence of hepatocellular carcinoma (HCC) as indicated by
a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance
imaging (MRI) within 3 months prior to Screening or a negative US at Screening.
Minimum age
12 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of severe, life-threatening or other clinically significant sensitivity to any
study drug or drug component.

- Female subject who is pregnant, breastfeeding or is considering becoming pregnant
during the study or for 4 months after the last dose of study drug, or as directed per
the local RBV label, whichever is more restrictive.

- Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator, and failure in an AbbVie HCV parent study due to non-virologic reasons.

- Positive test result at Screening for hepatitis B surface antigen (HBsAg).

- Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.

- Discontinuation from the AbbVie HCV parent study for reasons other than virologic
failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse
event).

- Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV
parent study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital /ID# 200944 - Herston
Recruitment hospital [2] 0 0
Royal Melbourne Hospital /ID# 155727 - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chengdu
Country [12] 0 0
China
State/province [12] 0 0
Chongqing
Country [13] 0 0
China
State/province [13] 0 0
Fuzhou
Country [14] 0 0
Germany
State/province [14] 0 0
Dusseldorf
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul Teugbyeolsi
Country [17] 0 0
New Zealand
State/province [17] 0 0
Waikato
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Dunedin
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Samarskaya Oblast
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Sweden
State/province [22] 0 0
Solna
Country [23] 0 0
Switzerland
State/province [23] 0 0
Bern
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of co-administration of
ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV)
genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with
compensated cirrhosis participants) who have experienced virologic failure in an AbbVie
parent clinical study.
Trial website
https://clinicaltrials.gov/show/NCT02939989
Trial related presentations / publications
Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8.
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications